U.S. Army Medical Research Institute of Infectious
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- Devices
- 1
What U.S. Army Medical Research Institute of Infectious makes
The U.S. Army Medical Research Institute of Infectious develops diagnostic tools for infectious disease detection, including the SMART LEISH system (Model LGM1-050), designed for rapid identification of Leishmania parasites in clinical samples.
The portfolio is regulated under FDA’s Class I device classification, with submissions supported via the 510(k) pathway. The institute is based in the United States.
Catalogue
Smart Leish, Model LGM1-050 Ref K081868
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does U.S. Army Medical Research Institute of Infectious have in the registry?
The registry currently lists 1 device for U.S. Army Medical Research Institute of Infectious. Devices recorded under merged duplicate company entries are counted once.
Which registries list U.S. Army Medical Research Institute of Infectious's devices?
Among its 1 most recently registered device, U.S. Army Medical Research Institute of Infectious has devices listed in FDA 510(k) (1 device).
What risk classes do U.S. Army Medical Research Institute of Infectious's devices fall under?
Among its 1 most recently registered device, the classes recorded for U.S. Army Medical Research Institute of Infectious's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from U.S. Army Medical Research Institute of Infectious in the registry?
The most recently registered devices listed for U.S. Army Medical Research Institute of Infectious include SMART LEISH, MODEL LGM1-050.